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Insulin SensitivityETAPANCT05572905

Effect of Acute Bout of Exercise on Levels of PAHSA

A study testing Exercise in people with Insulin Sensitivity, run by Lenka Rossmeislova at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Exercise represents an important tool in the prevention and treatment of metabolic disorders associated with obesity and aging, such as type 2 diabetes and cardiovascular disease. Read more about this study

Who is it for?
Ages 25 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Insulin Sensitivity
What is being tested?
Exercise
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCzechia
Study dates
1 May 2021to 12 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • healthy young lean, young obese and older omnivorous men and women as defined by BMI, self-reported activity, self-reported medical history and self-reported diet assessment
  • must be able to withstand repeated blood draws
  • must be able to undergo abdominal fat biopsy

Who cannot join

  • use of betablockers
  • use of glucocorticoids
  • use of non-steroidal anti-inflammatory drugs
  • use of metformin in prediabetes
  • use of psychiatric drugs such as selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, anticonvulsants and others
  • oncologic malignancy
Show all 14Show fewer
  • chronic inflammatory or autoimmune diseases
  • diabetes mellitus
  • chronic ischemic heart disease
  • cardiovascular and pulmonary disease
  • renal and hepatological disease as assessed per biochemistry
  • musculo-skeletal deviations limiting physical performance
  • substance abuse
  • other than omnivorous diet

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • 3rd faculty of medicine, Charles University

    Prague, Prague, 10000

Other trials in Czechia

About this study

Official title: Novel Approaches to Enhance Insulin-sensitizing Effects of Exercise: Targeting PAHSA Metabolism

Exercise represents an important tool in the prevention and treatment of metabolic disorders associated with obesity and aging, such as type 2 diabetes and cardiovascular disease. Besides skeletal muscle and its myokinins, the metabolic effects of exercise also rely on the induction of favorable changes in adipose tissue function. For example, adipose tissue is a source of lipokinins from the family of palmitic acid esters of hydroxy fatty acids (PAHSA), which have anti-inflammatory and insulin-sensitizing properties. We have recently shown that 4 months of exercise training increases PAHSA levels in adipose tissue and circulation. However, the mechanisms involved in the induction of PAHSA levels in response to exercise are unknown. The aim of the Effect of Acute Bout of Exercise on Levels of PAHSA (ETAPA) project is therefore to investigate the regulation of PAHSA metabolism in response to both acute and chronic exercise. To achieve this goal, we will employ state-of-the-art analytical methods to measure PAHSA levels in both adipose tissue and circulation of subjects of various ages and adiposity status. The main output of the ETAPA project will be the proof of principle regarding the important role of PAHSA lipokinins in exercise-induced enhancement of insulin sensitivity and the identification of potential drug targets that could be used to further improve PAHSA metabolism for the treatment of metabolic disorders associated with aging or obesity.

Being tested
Exercise, Fasting control
Keywords
acute exercise, adipose tissue, insulin sensitivity, PAHSA, lipokines, FAHFA
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    Patients after overnight fast will cycle on ergo-meter for 60 minutes. No per-oral food intake will be allowed during the test. Level of the intensity of exercise will be determined as individual range of heart frequency (HF), oxygen consumption (VO2) and respiratory quotient (RQ) just bellow the aerobic threshold of the given participant (close to anticipated fatmax). These values will be obtained during maximal capacity stress test on cyclo-ergo-meter. This maximum stress test will be performed at least one week prior to the 60 minutes exercise to eliminate potential carry-over effect. Power output will be modulated during the 60 minutes of exercise to ensure keeping participants values of HF, RQ and VO2 in the given range. Blood will be sampled at 5 time points with interval of 30 minutes during the exercise (0, 30, 60, 90, 120) and 24 hours post-exercise.

  • Fasting controlOther

    The same participants will be monitored while resting for 120 minutes in calm environment. No peroral food intake will be allowed during the test. Fasting control will take place at least one week apart of the exercise. Blood will be sampled at 5 timepoints with interval of 30 minutes during the exercise (0, 30, 60, 90, 120) and 24 hours post-control.

Study groups in NCT05572905
Study groupRoleWhat they receive
Young lean men and womenExperimental25 to 40 y.o. participants with body mass index in range of 18.5 to 25
Receives: Other: Exercise; Other: Fasting control
Young obese men and womenExperimental25 to 40 y.o. participants with body mass index in range of 30 to 45.
Receives: Other: Exercise; Other: Fasting control
Elderly men and womenExperimental65 to 80 y.o. participants with body mass index in range of 18.5 to 30.
Receives: Other: Exercise; Other: Fasting control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of PAHSA levels and its changes in response to exercise and fasting in cohorts differing in age and fat mass

    PAHSA levels [nmol/l] in serum sampled at pre-set time-points during control and intervention visits (including exercise session or plain fasting) and in subcutaneous abdominal white adipose tissue will be assessed by quantitative targeted lipidomic analysis.

    Absolute and fold-change of PAHSA in plasma induced by experimental intervention (exercise, fasting) will be compared among individual cohorts.

    Measured: 2 years

Secondary outcomes (2)

  1. Correlation of PAHSA levels with anthropometry and clinical characteristics

    Basal levels of PAHSA and its changes in response to interventions will be correlated with anthropometric parameters (age, weight, fat mass) and parameters of physical fitness. Fat mass will be assessed by dual energy X-ray absorptiometry. Intercohort matching of obese and elderly subjects based on fat mass will be improved throughout the recruitment phase by utilization of fat mass assessment on two distinct certified bioimpedance instruments. Cohort physical fitness will be calculated as average from individual VO2max values obtained from maximum ergometry testing. Intercohort matching of young lean and young obese men and women will be based on age.

    Measured: 2 years

  2. Correlation of PAHSA with various indexes of insulin sensitivity

    Basal levels of PAHSA and its changes in response to interventions will be correlated with indices of muscle insulin sensitivity (MISI), hepatic insulin resistance (HIRI), adipose tissue insulin resistance (Adipo-IR) and homeostatic model assessment of insulin resistance (HOMA-IR). Values for measurement will be obtained by biochemical analysis of blood sampled during 5-point oral glucose tolerance test.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study start1 May 2021
  3. Primary completion12 Dec 2025
  4. Study completion12 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Crossover
Model description
single groups assignment
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05572905
Sponsor's protocol ID
NU21-01-00469
Acronym
ETAPA
Status last verified
Dec 2025
First submitted
26 Sep 2022
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brezinova M, Kuda O, Hansikova J, Rombaldova M, Balas L, Bardova K, Durand T, Rossmeisl M, Cerna M, Stranak Z, Kopecky J. Levels of palmitic acid ester of hydroxystearic acid (PAHSA) are reduced in the breast milk of obese mothers. Biochim Biophys Acta Mol Cell Biol Lipids. 2018 Feb;1863(2):126-131. doi: 10.1016/j.bbalip.2017.11.004. Epub 2017 Nov 14.

    PubMed 29154942

  • Paluchova V, Oseeva M, Brezinova M, Cajka T, Bardova K, Adamcova K, Zacek P, Brejchova K, Balas L, Chodounska H, Kudova E, Schreiber R, Zechner R, Durand T, Rossmeisl M, Abumrad NA, Kopecky J, Kuda O. Lipokine 5-PAHSA Is Regulated by Adipose Triglyceride Lipase and Primes Adipocytes for De Novo Lipogenesis in Mice. Diabetes. 2020 Mar;69(3):300-312. doi: 10.2337/db19-0494. Epub 2019 Dec 5.

    PubMed 31806624

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Insulin Sensitivity, run by Lenka Rossmeislova at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of PAHSA levels and its changes in response to exercise and fasting in cohorts differing in age and fat mass (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05572905, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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